Are you a seasoned Clinical Data Management professional, looking forward to an exciting mission within your expertise of data delivery ? Then this assignment may be what you are looking for, this position is entirely remote.
The Clinical Data Standards Architect (CDSA)- Data Delivery implements and maintains efficient standard content in the data delivery tools (SAS, LSAF Excel based libraries) that can be applied across all the diseases areas and therapeutic areas or that are specific to a specific therapeutic are or disease area.
The CDSA defines and maintains the standard delivery metadata supporting the data flow from data collection to data delivery (DRM and SDTM). To that end, the CDSA is responsible for defining and maintaining the metadata supporting the Data transfer Agreements (DTA) with third parties, DRM and SDTM model and the data mapping of source data, eCRF data and third-party transfer data (eDT) to DRM and SDTM
The CDSA configures standards to the specific needs and requirements of a Therapeutic Area, compound, or Disease Area, generating the expected efficiencies through optimal adoption and reuse of standards.
- TheCDSA implements the standardmetadata in the data delivery tools with the goal of creatingefficiencies within the trials, consistency across the trials and automating the data flow from source data toDRM and toSDTM. Examples:
- Study Data Tabulation Model (SDTM) o Annotated Case Report Forms (CRFs)
- Support the data transfer agreement (DTA) standards with SDTM
- Data Review Model (DRM) o Mapping metadata from data collection (CRF and DTA) to DRM
- The CDSA implements standard content in the delivery tools compliant to the industry standards and health authority regulations, meeting best practices in computer system validation, where applicable.
- The CDSA defines and maintains the clinical data delivery standards in line with the needs in clinical trials to meet additional scientific or operational requirements. To that end the CDSA will guarantee that formal change management control and versioning of the standards is applied and adhered to. The CDSA governs formally all the changes to standards and manages multiple versions in line with adoption needs of the clinical trials and drug development programs.
- The CDSA provides the necessary support to the clinical programming teams to achieve consistent adoption of standards in the studies (internally or outsourced to a CRO). To that end, the CDSA proactively support identifying the standards supporting the trial objectives.
- The CDSA tailors the global standards to the specific needs of Therapeutic Areas or Disease Ares, while maintaining the traceability and lineage of the metadata. The CDSA documents and correctly manages the lineage between global standards and the pre-configured (tailored) standards.
- The CDSA provides the necessary support to the clinical programming teams to achieve consistent adoption of standards in the studies (internally or outsourced to a CRO). To that end, the CDSA proactively support identifying the standards supporting the trial objectives. Interfaces - Primary/Other:
- Primary interfaces: The clinical data standards team and the data acquisition experts and the data managers in the data management function and the clinical programmers.
- Other Interfaces: Clinical Analysis Standards, the clinical team (statistician, physician, …), CDISC working groups.
Do the above responsibilities fit you like a glove?
Upload your CV and motivation letter via the "apply now" button and you can expect feedback from us soon.
If something is not entirely clear, you can reach out to us by telephone of course.
- Experience with coding and running SAS programs is required
- Knowledge of Rave eDC (Medidata Solutions) is a preferred
- Expertise with CDISC standards: SDTM, Controlled terminology and define.xml.
- Experience with SAS LSAF and Pinnacle 21 is a plus
- BS/BA degree in life sciences or computer science or equivalent by work experience
- 3 years of relevant operational experience in clinical data management and standards
- Relevant development experience in clinical data standards is strongly preferred
- Experience in prioritizing and managing multiple tasks simultaneously
- Outstanding written and verbal communication skills in English
- A balanced salary package based on your capabilities and experience.
Existing right to work in Europe required ( please read job spec in full before applying ).
Vacancy number : 17877